You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 076763

✉ Email this page to a colleague

« Back to Dashboard

NDA 076763 describes CLOTRIMAZOLE, which is a drug marketed by Fougera Pharms, Glenmark Pharms, Sun Pharma Canada, P And L, Novitium Pharma, Sciegen Pharms Inc, Teva, Tp Anda Holdings, Hikma, Padagis Us, Thinq Pharm-cro Pvt, Actavis Mid Atlantic, Glenmark Speclt, and Taro, and is included in nineteen NDAs. It is available from twenty-three suppliers. Additional details are available on the CLOTRIMAZOLE profile page.

The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for 076763

Tradename:	CLOTRIMAZOLE
Applicant:	Padagis Us
Ingredient:	clotrimazole
Patents:	0

Pharmacology for NDA: 076763

Medical Subject Heading (MeSH) Categories for 076763

14-alpha Demethylase Inhibitors
Anti-Infective Agents, Local
Antifungal Agents

Suppliers and Packaging for NDA: 076763

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOTRIMAZOLE	clotrimazole	TROCHE/LOZENGE;ORAL	076763	ANDA	Padagis US LLC	0574-0107	0574-0107-14	140 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-14)
CLOTRIMAZOLE	clotrimazole	TROCHE/LOZENGE;ORAL	076763	ANDA	Padagis US LLC	0574-0107	0574-0107-70	70 LOZENGE in 1 BOTTLE, PLASTIC (0574-0107-70)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TROCHE/LOZENGE;ORAL			Strength	10MG
Approval Date:	Oct 28, 2005	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.